Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study

Anesthesia Clinical Trial

Official title:

A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03393988
• Other study ID #: FMASU R45/2017
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 23, 2017
• Last updated: January 8, 2018
• Start date: December 7, 2017
• Est. completion date: February 2019

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesia (ASA) physical status I or II

• Scheduled as live liver donors

• J-shaped incision in the supraumblical region

Exclusion Criteria:

• Patients with a history of psychiatric/neurological illness,

• Hypertensive patients,

• Morbidly obese patients,

• Pregnant and nursing women,

• Patients with known allergic reaction to any of the study medications,

• Patients on recent use of sedatives or analgesics,

• Patients with significant laboratory abnormalities

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Fentanyl infusion
After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).

Procedure:
• Ultrasound guided TAP block
After induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery.

Drug:
• Dexmedetomidine
Dexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 µg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 µg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading)

Locations

Country	Name	City	State
Egypt	Hospitals of Faculty of Medicine , Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fentanyl consumption	Total Intravenous fentanyl consumption during the operation	Intraoperative
Secondary	Average sevoflurane concentration	The average sevoflurane concentration (the average concentration (%) for the case will be determined from the vaporizer setting recorded in the anesthetic record per 5-minute interval)	Intraoperative
Secondary	The severity of postoperative nausea and vomiting (PONV)	Will be recorded and classified as "no PONV, mild PONV, moderate PONV and severe PONV"	First 24 hours postoperatively
Secondary	Ramsay sedation score (RSS)	Will be used for assessment of sedation immediately after extubation, after 2 hours of ICU admission, after 12 hours then after 24 hours .	First 24 hours postoperatively